Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women (TTH-MT)

Comparison of the Effect of Manuel Therapy on Tension Type Headache in Menopausal and Premenopasual Women

This study aims to investigate the effectiveness of manual therapy in women with tension-type headache and to compare treatment outcomes between menopausal and premenopausal women. Hormonal changes occurring during menopause may influence pain perception and headache characteristics.

Participants diagnosed with tension-type headache will receive manual therapy interventions. Headache intensity, headache-related disability, pressure pain threshold, cervical range of motion, sleep quality, and quality of life will be evaluated before and after treatment using validated assessment tools. The results are expected to contribute to physiotherapy approaches in women experiencing tension-type headache during different hormonal periods.

Study Overview

• Status: Recruiting
• Conditions: Tension Type Headache
• Intervention / Treatment: Procedure: Manuel Therapy

Detailed Description

Tension-type headache (TTH) is the most prevalent type of primary headache and is characterized by bilateral, pressing, or tightening pain of mild to moderate intensity. It has a considerable impact on daily activities, psychological status, sleep quality, and overall quality of life. Hormonal changes occurring during the menopausal transition may influence pain perception, musculoskeletal sensitivity, and headache characteristics. Therefore, investigating treatment responses in different hormonal periods may provide valuable clinical insights.

The aim of this study is to investigate and compare the effectiveness of manual therapy applications in menopausal and premenopausal women with tension-type headache. The study will include women diagnosed with tension-type headache who meet the inclusion criteria. Participants will be evaluated before and after the intervention period.

Manual therapy interventions including soft tissue techniques, cervical mobilization, and therapeutic exercises will be applied. Outcome measures will include headache intensity assessed with the Visual Analog Scale (VAS), headache-related disability evaluated using the Headache Impact Test (HIT-6), pressure pain threshold measured by algometer, cervical range of motion assessed using a goniometer, sleep quality evaluated with the Pittsburgh Sleep Quality Index (PSQI), and health-related quality of life measured with the Short Form-36 (SF-36).

The results of this study are expected to provide evidence regarding the role of manual therapy in the management of tension-type headache and contribute to physiotherapy practices targeting women in different hormonal stages.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayça Seda Yıldırımer, PT, MSc; Phone Number: +90 507 409 08 99; Email: aycaseda29@gmail.com

Study Locations

• Turkey (Türkiye)
  • Konya
    • Konya, Konya, Turkey (Türkiye), 42090
      • Recruiting
      • Necmettin Erbakan Univesity Faculty of Health Sciences
      • Contact: Ayça Seda Yıldırımer, PT; Phone Number: +90 507 409 08 99; Email: aycaseda29@gmail.com
      • Principal Investigator: Neslihan Altuntaş Yılmaz, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female participants aged between 45 and 65 years.
• Diagnosis of tension-type headache.
• Premenopausal or menopausal status.
• HIT-6 score of 49 or higher.
• Willingness to participate in the study.

Exclusion Criteria:

• Use of hormone therapy.
• History of cervical surgery.
• History of neurological disease.
• Pregnancy.
• Inability to understand questionnaire forms.
• Failure to attend treatment sessions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premenopausal Women With Tension-Type Headache; Premenopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study.	Procedure: Manuel Therapy; Participants diagnosed with tension-type headache will receive manual therapy interventions including cervical mobilization, soft tissue techniques, and suboccipital muscle relaxation. Treatments will be applied by a physiotherapist during the study period.
Experimental: Menopausal Women With Tension-Type Headache; Menopausal women diagnosed with tension-type headache who will receive manual therapy interventions during the study.	Procedure: Manuel Therapy; Participants diagnosed with tension-type headache will receive manual therapy interventions including cervical mobilization, soft tissue techniques, and suboccipital muscle relaxation. Treatments will be applied by a physiotherapist during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain İntensity (Visual Analog Scale - VAS)	Pain intensity will be assesed using the Visual Analog Scale (VAS). Participants will rate their pain on a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain)	Baseline and after 2 weeks of treatment
Headache İmpact (Headache İmpact Test - HİT-6)	Headache-related disability will be evaluted using the Headache İmpact Test (HİT-6). This questionnaire assesses the impact of headaches on daily functioning, social activities and overall quality of life.	Baseline and after 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)	Sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), a self-reported questionnaire that assesses sleep quality and disturbances over the previous month. Higher scores indicate poorer sleep quality.	Baseline and after 2 weeks of treatment
Pressure Pain Threshold	Pressure pain threshold will be measured using a digital algometer applied to the pericranial muscles. The minimum pressure that induces pain will be recorded.	Baseline and after 2 weeks of treatment
Cervical Range of Motion	Cervical range of motion will be assessed using a universal goniometer to evaluate cervical flexion, extension, lateral flexion, and rotation movements.	Baseline and after 2 weeks of treatment
Executive Function (Trail Making Test Part B)	Executive function and cognitive flexibility will be assessed using the Trail Making Test Part B (TMT-B). The test evaluates visual attention, processing speed, and task-switching ability. The time required to complete the test will be recorded.	Baseline and after 2 weeks of treatment
Depression Severity (Beck Depression Inventory)	Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire designed to measure the severity of depressive symptoms.	Baseline and after 2 weeks of treatment
Quality of Life (SF-12)	Health-related quality of life will be assessed using the SF-12 Short Form Health Survey. The SF-12 evaluates physical and mental components of health-related quality of life. Higher scores indicate better health-related quality of life.	Baseline and after 2 weeks of treatment

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Principal Investigator: Neslihan Altuntaş Yılmaz, PhD, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Women; Menopause; Physiotherapy; Tension Type Headache; Premenopause; Manuel Therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Tension-Type Headache
• Other Study ID Numbers: TTH_MT_MENOPAUSE_2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: İndividual participant data collected during this study will not be publicly shared. The data will be used only for the purposes of this research and will be stored securely bu the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No